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CompletedNCT05574803Updated Jan 18, 2024

High-definition tDCS Treatment for Cantonese-speaking Adults Who Stutter

An interventional study of Active-tDCS and Sham-tDCS in Stuttering, Adult and Stammering, sponsored by The Hong Kong Polytechnic University. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-01-18.

Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jul 2021, registered Oct 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The proposed study aims to investigate the effect of combined transcranial direct current stimulation (tDCS) and behavioural speech training in improving speech fluency in Cantonese-speaking adults who stutter (AWS), and to examine its maintenance over a 6-week period.

Read the detailed description

The proposed study aims to

  1. assess the effect of multiple sessions of tDCS over the supplementary motor area (SMA) combined with behavioural speech training on stuttering recovery in terms of a reduction of stuttering severity and increased speech satisfaction in Cantonese-speaking AWS;
  2. investigate the maintenance of combined tDCS-behavioural speech training effects on speech fluency and speech satisfaction in Cantonese-speaking AWS over a 6-week period.

Twenty Cantonese-speaking AWS will be randomly assigned to an experimental group and a control group. Both groups will receive behavioral treatment for stuttering, including the speech prolongation technique, for five sessions. Concurrent with behavioural training, the experimental group will receive anodal tDCS (1 mA for 20 minutes), while the control group will receive sham tDCS (1 mA for one minute), over the SMA. Stuttering severity and speech satisfaction will be assessed independently before, immediately after, one week and six weeks after treatment. It is anticipated that AWS will experience reduction in their stuttering severity after stimulation, and the improvement will be maintained for a longer period as compared with receiving behavioural treatment alone.

02

Conditions studied

  • Stuttering, Adult
  • Stammering

Keywords

  • tDCS
  • Stuttering
  • Speech therapy
  • Camperdown Program
03

In context

Stuttering

74 studies on the registry are indexed under Stuttering; 23 are open to participants now.

This study's enrollment of 10 is below the median of 44 across 57 interventional studies indexed under Stuttering.

Browse Stuttering studies →

Lead sponsor

The Hong Kong Polytechnic University is the lead sponsor of 679 studies on the registry; 257 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Demonstrated features of stuttering;
  • More than 2% of syllables stuttered over three baseline speech samples, as measured by qualified speech therapists.

Exclusion criteria

Exclusion Criteria:

  • Personal or family history of epilepsy or seizures
  • History of a neurological condition
  • Speech disorders
  • Hearing impairment
  • Metallic foreign body implant
  • On medications that lower neural thresholds (e.g. tricyclines, antidepressants, neuroleptic agents, etc.)
  • Pregnant
  • Had speech therapy for stuttering in the past four months
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Active tDCS

    The experimental group will receive 20 minutes of anodal HD-tDCS for five sessions, combined with 20 minutes of behavioural therapy.

    Device: Active-tDCS

  • Sham comparator
    Sham tDCS

    The control group will only receive one minute of anodal HD-tDCS stimulation which aims to create a similar sensation on the scalp as those in the experimental group, with 20 minutes of behavioural therapy.

    Device: Sham-tDCS

Interventions

  • DeviceActive-tDCS

    Active-tDCS (1 mA) over the supplementary motor area (SMA) for 5 sessions (20 minutes per session, weekly), along with behavioural therapy of speaking tasks (i.e., story narration and conversation) using the minimum prolongation technique based on the Camperdown Program.

  • DeviceSham-tDCS

    Sham-tDCS (1 mA) over the supplementary motor area (SMA) for 5 sessions (one minutes per session, weekly), along with behavioural therapy of speaking tasks (i.e., story narration and conversation) using the minimum prolongation technique based on the Camperdown Program. Participants will receive initial stimulation for one minute, eliciting a tingling sensation on the scalp then it will be discontinued.

06

What researchers measure

Primary outcomes

  1. Stuttering severity [Percent syllables stuttered (%SS)]

    %SS is based on the proportion of spoken syllables that a judge perceives to be stuttered. It will be measured by a qualified speech therapist with prior training in stuttering assessment in Cantonese who will be blinded to the treatment conditions. To establish inter-rater agreement, 20% of the speech samples across different assessment data points will be randomly selected and rated by a second speech therapist.

    Time frame: Change before, immediately after, one week and six weeks after treatment

  2. Stuttering severity [Severity rating (SR)]

    The subjects will be trained to rate their own stuttering severity based on a 9-point SR scale, with 0 = no stuttering, 1 =very mild stuttering, and 8 = the most severe stuttering.

    Time frame: Change before, immediately after, one week and six weeks after treatment

Secondary outcomes

  1. Subject satisfaction

    For the assessment of subject satisfaction regarding the treatment, the following two Likert-type survey questions will be asked: 1. How much do you think the treatment helped you to speak more fluently? (1 = not at all, 2 = a little, 3 = somewhat, 4 = a lot, 5 = totally); and 2. How often/much do you think the treatment helped you to feel less stressed in your communication? (1 = never or not at all, 2 = rarely or a little, 3 = sometimes or somewhat, 4 = often or a lot, 5 = always or totally).

    Time frame: One week and six weeks after treatment

07

Study locations

1 site
  • The Hong Kong Polytechnic University
    Kowloon, Hong Kong
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2021 to primary completion in Dec 2023, 29 months.

Of 37 interventional studies with no phase under Stuttering, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 38. This study's 29 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 7, 2022
First posted
Oct 12, 2022
StartActual
Jul 27, 2021
Primary completionActual
Dec 31, 2023
CompletionActual
Dec 31, 2023
Last update
Jan 18, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05574803
Responsible party
Dr Min Wong (Assistant Professor, The Hong Kong Polytechnic University) — Principal investigator
First posted
Oct 12, 2022
Start date
Jul 27, 2021
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023
Last update
Jan 18, 2024

Study contacts

Min Ney Wong, PhD
principal investigator · The Hong Kong Polytechnic University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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